Effectiveness, safety and persistence of filgotinib in rheumatoid arthritis with a specific focus on difficult-to-treat patients: results from a multicentre observational study.
11 affiliations
- 1Rheumatology Unit, Department of Medicine (DIMED), University of Padova, Padova, Italy.
- 2Rheumatology Unit, Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy.
- 3Rheumatology and Clinical Immunology, ASST Spedali Civili Brescia, Brescia, Italy.
- 4Rheumatology Unit, ASST Ovest Milanese, Legnano (MI), Italy.
- 5Rheumatology Unit, ASST Papa Giovanni XXIII, Bergamo (BG), Italy.
- 6Rheumatology Unit, Central Hospital of Bolzano (ASAA-SABES), Teaching Hospital of the Paracelsus Medical University, Bolzano (BZ), Italy.
- 7General Medicine 1, Regional Centre for Rare Immunological and Rheumatological Diseases, Ospedale Universitario Treviso, Treviso, Italy.
- 8Rheumatology Unit, ASST FBF SACCO Milano, Milano, Italy.
- 9Rheumatology Unit, Azienda Sanitaria Friuli Occidentale (ASFO), Pordenone (PN), Italy.
- 10Rheumatology Unit, Department of Medicine (DIMED), University Hospital of Padova, Padova, Italy.
- 11Rheumatology Unit, Department of Medicine (DIMED), University of Padova, Padova, Italy. [email protected].
Abstract
Background
Filgotinib, a preferential JAK1 inhibitor, is among the most recently approved therapies for rheumatoid arthritis (RA). Real-world evidence remains limited, particularly for difficult-to-treat RA (D2T) patients, who are underrepresented in clinical trials. We therefore evaluated the efficacy, safety, and treatment persistence of filgotinib in a large cohort of patients with RA, with a specific focus on those with D2T RA.Methods
This retrospective multicentre study included patients with RA (ACR/EULAR 2010 criteria) treated with filgotinib across nine Italian centres. Patients were followed every 3-6 months for up to 3 years, with collection of clinical variables, laboratory data, and adverse events (AEs).Results
A total of 254 patients were included (mean age 58 ± 12 years; 85% female), of whom 47% had D2T disease. Disease activity indices (CDAI, DAS28-CRP, PGA, PhGA) improved significantly from baseline (p < 0.001), with remission rates reaching 41.3% (CDAI) and 70.5% (DAS28-CRP). Glucocorticoid (GC) use decreased from 64.4% to 32.6%. Improvements in disease activity and the GC-sparing effect were comparable between D2T RA and non-D2T RA patients. During follow-up, 153 AEs were reported, including 13 serious AEs and one infection-related death; non-serious infections were the most frequent events. Lipid profile remained stable throughout the study period, and two major cardiovascular events were reported. Treatment persistence was 88.4% at 6 months and 68% at 24 months, with no significant differences between D2T RA and non-D2T RA patients.Conclusions
Filgotinib demonstrated effective disease control, good safety and high treatment persistence in a real-world RA population, including a high proportion of D2T patients.
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BibTeX
@article{osele2026effectiveness,
title = {{Effectiveness, safety and persistence of filgotinib in rheumatoid arthritis with a specific focus on difficult-to-treat patients: results from a multicentre observational study.}},
author = {Anna Giorgia Osele and Mariangela Salvato and Antonio Carletto and Matteo Filippini and Eugenio Capparelli and Eleonora Bruschi and Bernd Raffeiner and Silvano Bettio and Donatella Ventura and Luca Picco and Elena Fracassi and Massimiliano Limonta and Filippo Montanari and Paola Faggioli and Maurizio Rossini and Elda Piovani and Eleonora Zaccara and Filippo Vesentini and Roberta Ramonda and Alessandro Giollo and Margherita Zen},
journal = {Arthritis research \& therapy},
year = {2026},
month = aug,
doi = {10.1186/s13075-026-03881-z},
url = {https://europepmc.org/article/MED/42972550},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Effectiveness, safety and persistence of filgotinib in rheumatoid arthritis with a specific focus on difficult-to-treat patients: results from a multicentre observational study.
AU - Anna Giorgia Osele
AU - Mariangela Salvato
AU - Antonio Carletto
AU - Matteo Filippini
AU - Eugenio Capparelli
AU - Eleonora Bruschi
AU - Bernd Raffeiner
AU - Silvano Bettio
AU - Donatella Ventura
AU - Luca Picco
AU - Elena Fracassi
AU - Massimiliano Limonta
AU - Filippo Montanari
AU - Paola Faggioli
AU - Maurizio Rossini
AU - Elda Piovani
AU - Eleonora Zaccara
AU - Filippo Vesentini
AU - Roberta Ramonda
AU - Alessandro Giollo
AU - Margherita Zen
PY - 2026
DA - 2026/08/06
JO - Arthritis research & therapy
DO - 10.1186/s13075-026-03881-z
UR - https://europepmc.org/article/MED/42972550
AB - Background Filgotinib, a preferential JAK1 inhibitor, is among the most recently approved therapies for rheumatoid arthritis (RA). Real-world evidence remains limited, particularly for difficult-to-treat RA (D2T) patients, who are underrepresented in clinical trials. We therefore evaluated the efficacy, safety, and treatment persistence of filgotinib in a large cohort of patients with RA, with a specific focus on those with D2T RA.Methods This retrospective multicentre study included patients with RA (ACR/EULAR 2010 criteria) treated with filgotinib across nine Italian centres. Patients were followed every 3-6 months for up to 3 years, with collection of clinical variables, laboratory data, and adverse events (AEs).Results A total of 254 patients were included (mean age 58 ± 12 years; 85% female), of whom 47% had D2T disease. Disease activity indices (CDAI, DAS28-CRP, PGA, PhGA) improved significantly from baseline (p < 0.001), with remission rates reaching 41.3% (CDAI) and 70.5% (DAS28-CRP). Glucocorticoid (GC) use decreased from 64.4% to 32.6%. Improvements in disease activity and the GC-sparing effect were comparable between D2T RA and non-D2T RA patients. During follow-up, 153 AEs were reported, including 13 serious AEs and one infection-related death; non-serious infections were the most frequent events. Lipid profile remained stable throughout the study period, and two major cardiovascular events were reported. Treatment persistence was 88.4% at 6 months and 68% at 24 months, with no significant differences between D2T RA and non-D2T RA patients.Conclusions Filgotinib demonstrated effective disease control, good safety and high treatment persistence in a real-world RA population, including a high proportion of D2T patients.
SN - 1478-6354
SN - 1478-6362
ER -